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U.S. Department of Health and Human Services

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Information on Conventional Antipsychotics

 

FDA ALERT [6/16/2008]: FDA is notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.

In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics.

Antipsychotics are not indicated for the treatment of dementia-related psychosis.

This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.

  • Conventional Antipsychotic Drugs:
    • Compazine (prochlorperazine) 
    • Haldol (haloperidol)
    • Loxitane (loxapine)
    • Mellaril (thioridazine)
    • Moban (molindone)
    • Navane (thithixene)                                     
    • Orap (pimozide)                                             
    • Prolixin (fluphenazine)                                   
    • Stelazine (trifluoperazine)                              
    • Thorazine (chlorpromazine)
    • Trilafon (perphenazine)

To report any serious adverse events associated with the use of these drugs, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857